The Recall Desk
HighFDA (Devices)·Z-0723-2026·Announced 2025-12-03

Imaging software recalled over a bug that can lose clinical information

Intelerad Medical Systems is recalling 19 IntelePACS InteleConnect and TechPortal installations because a bug can cause data loss in the Relevant Clinical Info field.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: lost clinical information can affect a reading and the decisions that follow, and no injuries are reported.

Plain-English summary

IntelePACS - InteleConnect / TechPortal, a software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored and displayed, is being recalled.

The software has a bug that could cause data loss in the Relevant Clinical Info field when modifying studies through Case Editor in either the Technologist Portal or the Referring Physician Portal. Intelerad states this could result in loss of clinical information, which could impact clinical decision-making.

The recall covers 19 installations carrying UDI-DI B228INTELEPACS0, across versions PACS-5-6-1-R64 through R68 distributed from 2 July 2025 to 10 September 2025. The product was distributed in Arizona, Connecticut, Alabama, Illinois, Washington, Maryland, New Jersey, California, Tennessee, Indiana, Florida and North Carolina. The FDA has classified the action as Class II.

Sites running an affected version should follow Intelerad's instructions.

The recalled product

Product
IntelePACS - InteleConnect / TechPortal
Manufacturer
INTELERAD MEDICAL SYSTEMS INCORPORATED
Category
Medical Device — Imaging software
Hazard
Affected units
19

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • PACS-5-7-1-R42 through R47/26 June 2025 - 25 Sep 2025
  • PACS 5-8-1-R20 through R23/26 Jun 2025 - 25 Sep 2025
  • PACS-5-9-1-R1 through R3/30 Jun 2025 - 09 Sep 2025

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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